Substance Abuse Treatment for High Risk Chronic Pain Patients on Opioid Therapy

NCT00988962 | Completed

• 1 other identifier: 2007p001732
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic back pain patients are often dismissed from a pain center or a primary care practice when they are noncompliant with opioid therapy, instead of being offered treatments to reduce misuse and to improve compliance. Unfortunately, there are few treatment resources for such patients. This study seeks to remedy that problem, with the goal of reducing the rate of prescription opioid misuse among noncompliant patients through the use of novel tracking, education, and counseling interventions.

Conditions

Substance Abuse

Keywords

pain; opioids

Outcome Measures

Primary Outcomes (1)

• Drug Misuse Index: 1) physician ratings of misuse (ABC), 2) structured self-report interview (PDUQ), and 3) urine tox screens

  All subjects will be followed for 6 months.

Secondary Outcomes (1)

• 1) Rate of patient dismissal from a pain center, 2) treatment satisfaction ratings

  Subjects will be followed for 6 months.

Study Arms (3)

High-Risk No Treatment

NO INTERVENTION

High-Risk Treatment

EXPERIMENTAL

Behavioral: cognitive behavioral training

Low-Risk

NO INTERVENTION

Interventions

cognitive behavioral training BEHAVIORAL

electronic diaries, compliance checklists, urine screens, individual and group motivational counseling

Also known as: compliance contract, therapy

High-Risk Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic pain for \>6 months
• history of taking daily opioids for pain for \>6 months
• average \>3 on a pain intensity scale of 0 to 10 over past week
• able to speak and understand English
• chronic neck or back pain as primary pain complaint
• willingness to participate

You may not qualify if:

• current opioid addiction (M.I.N.I. Section K)
• current diagnosis of cancer or any other malignant disease
• acute osteomyelitis or acute bone disease
• nonambulatory
• present or past DSM-IV diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder
• pregnancy
• any clinically unstable systemic illness judged to interfere with treatment
• an acute condition requiring surgery
• taking opioids intermittently

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Brigham and Women's Hospital Pain Management Center

Chestnut Hill, Massachusetts, 02467, United States

Location

Related Publications (9)

• Wasan AD, Butler SF, Budman SH, Fernandez K, Weiss RD, Greenfield SF, Jamison RN. Does report of craving opioid medication predict aberrant drug behavior among chronic pain patients? Clin J Pain. 2009 Mar-Apr;25(3):193-8. doi: 10.1097/AJP.0b013e318193a6c4.

  PMID: 19333168 BACKGROUND

• Wasan AD, Michna E, Janfaza D, Greenfield S, Teter CJ, Jamison RN. Interpreting urine drug tests: prevalence of morphine metabolism to hydromorphone in chronic pain patients treated with morphine. Pain Med. 2008 Oct;9(7):918-23. doi: 10.1111/j.1526-4637.2007.00354.x. Epub 2007 Aug 28.

  PMID: 18616432 BACKGROUND

• Butler SF, Fernandez K, Benoit C, Budman SH, Jamison RN. Validation of the revised Screener and Opioid Assessment for Patients with Pain (SOAPP-R). J Pain. 2008 Apr;9(4):360-72. doi: 10.1016/j.jpain.2007.11.014. Epub 2008 Jan 22.

  PMID: 18203666 BACKGROUND

• Marceau LD, Link C, Jamison RN, Carolan S. Electronic diaries as a tool to improve pain management: is there any evidence? Pain Med. 2007 Oct;8 Suppl 3:S101-9. doi: 10.1111/j.1526-4637.2007.00374.x.

  PMID: 17877520 BACKGROUND

• Butler SF, Budman SH, Fernandez KC, Houle B, Benoit C, Katz N, Jamison RN. Development and validation of the Current Opioid Misuse Measure. Pain. 2007 Jul;130(1-2):144-56. doi: 10.1016/j.pain.2007.01.014. Epub 2007 May 9.

  PMID: 17493754 BACKGROUND

• Akbik H, Butler SF, Budman SH, Fernandez K, Katz NP, Jamison RN. Validation and clinical application of the Screener and Opioid Assessment for Patients with Pain (SOAPP). J Pain Symptom Manage. 2006 Sep;32(3):287-93. doi: 10.1016/j.jpainsymman.2006.03.010.

  PMID: 16939853 BACKGROUND

• Butler SF, Budman SH, Fernandez K, Jamison RN. Validation of a screener and opioid assessment measure for patients with chronic pain. Pain. 2004 Nov;112(1-2):65-75. doi: 10.1016/j.pain.2004.07.026.

  PMID: 15494186 BACKGROUND

• Michna E, Ross EL, Hynes WL, Nedeljkovic SS, Soumekh S, Janfaza D, Palombi D, Jamison RN. Predicting aberrant drug behavior in patients treated for chronic pain: importance of abuse history. J Pain Symptom Manage. 2004 Sep;28(3):250-8. doi: 10.1016/j.jpainsymman.2004.04.007.

  PMID: 15336337 BACKGROUND

• Nedeljkovic SS, Wasan A, Jamison RN. Assessment of efficacy of long-term opioid therapy in pain patients with substance abuse potential. Clin J Pain. 2002 Jul-Aug;18(4 Suppl):S39-51. doi: 10.1097/00002508-200207001-00005.

  PMID: 12479253 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders; Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert N Jamison, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 30, 2009
• First Posted: October 2, 2009
• Study Start: July 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 27, 2011

Record last verified: 2011-06

Locations

US (1)